510(k) Report

Devices descending from K141158

9 later devices reach APEX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142506TensCare KegelFitTenscare, Ltd.20154—
+1K150183ApexMIncontrol Medical, LLC20153—
+2K191312Perfect PFETenscare, Ltd.20193—
+2K182022ApexMVIncontrol Medical, LLC20191—
+2K163288Pelvifine Pelvic Muscle TrainerShenzhen Konmed Technology Co., Ltd.20180—
+3K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.20260—
+3K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer…Hunan Accurate Bio-Medical Technology Co., Ltd.20260—
+3K251760Well-Life Incontinence Stimulation System (WL-2405i (P))Well-Life Healthcare, Ltd.20260—
+3K230983Unicare (K-UNICARE-USA)Tenscare, Ltd.20230—